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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS055
Date Received10/04/1994
Decision Date02/13/1996
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for component and process change to the nucleus 22 channel cochlear implant device. The component change consists of replacing the lower value npo dielectric trim capacitor with the same bx dielectric material as used for the higher value trim capacitor. The process change consists of preheating the capacitors and printed circuit board prior to soldering the capacitors to the pcb.
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